Wyeth has denied breaching the inclusion/exclusion criteria for a paediatric vaccines trial in India that was suspended following the death of one of the children taking part.

Drugs Controller General Dr Surinder Singh was quoted in the local media as saying that the infant who died had a pre-existing cardiac abnormality and should never have been included in the trial. Wyeth insists this was a “retrospective hypothesis generated by the investigator”, while noting that the child involved was in the control group and did not receive the experimental vaccine.

The trial sponsored by Wyeth and conducted by GVK Biosciences – described by the US company as “one of the most well respected pharmaceutical research organisations in India” – was of Wyeth’s investigational 13-valent vaccine for the prevention of pneumococcal disease (PD). A total of 354 children were taking part and the reported death occurred at a large academic medical centre in Bangalore. The study has been suspended pending a review of the death by the Drugs Controller General.

The infant who died “was in the control group, which did not receive the investigational vaccine but instead received routinely recommended vaccines at each visit, plus Wyeth’s Prevenar, which has been used to help protect children from PD for more than eight years, has a well-documented safety profile and has been studied in more than 160,000 children”, the company said. It has not been established that the child who died had a pre-existing medical condition, it added.

“Based on our review of the case, screening, enrolment and dosing was handled properly,” Wyeth told PharmaTimes clinical new e-lert “There doesn’t appear to have been any reason based on the medical history to have excluded the child from the study.” The company will now work with the Drugs Controller General “to support his review of this case and will wait for his office to provide further guidance”, it said.

While GVK Biosciences acted as the contract research organisation for the vaccine trial, Wyeth “works in full partnership with clinical research organisations and investigators – including protocol development, training of investigators and monitoring”, it noted.

The flood of clinical trials into India has inevitably raised concerns about quality, oversight and informed consent. Recently it has looked as though the Indian government is finally moving to ease restrictions on outsourcing of Phase I trials to the country.

However, sensitivities were inflamed in August by the revelation that 49 young children had died in clinical trials at the prestigious All India Institute of Medical Scientists (AIIMS) since the beginning of January 2006. While there was no clear evidence that the deaths were related to drugs used in the trials, suspicions were fanned by the presence of five ‘foreign-manufactured’ pharmaceuticals among the various interventions used in the AIIMS studies.

According to a report published last month by Indian research firm RNCOS, India is one of the fastest growing vaccines markets in the world, worth around INR 39 billion (US$900 million) in 2006-07. The last few years have seen a dramatic increase in the market presence of multinational players such as GlaxoSmithKline, Wyeth, Sanofi-Aventis and Eli Lilly, RNCOS noted.